FDA.reportPublic FDA data

Alere iScreen Dx

Primary DI
00817405020126
Brand
Alere iScreen Dx
Company
Instant Technologies, Inc.
Model
IS1 TCA-DX
Catalog number
IS1 TCA-DX
Device description
Urine Drug Screen Card for detection of Tricyclic Antidepressants (TCA) single drug, CLIA Waived
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFHU.V. Spectrometry, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFHU.V. Spectrometry, Tricyclic Antidepressant DrugsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022355000QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61Branan Medical Corp.2002-07-30DIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817405020126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817405020126008174050201268174050201260817405020126

GMDN Terms#

Term, Definition table
TermDefinition
Tricyclic antidepressant IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of tricyclic antidepressant drugs in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-340-4029xxx@xx.xx
1-800-340-4029Qa.Portsmouth@abbott.com

Regulatory Flags#

DUNS number
019410187
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817405024025iCassetteABTDFYW11201AABTDFYW11201A2023-11-30
00817405021154UScreen®USSCup-10MUSSCup-10M2021-01-13
00817405021192UScreen®USSCupA-12CLIAUSSCUPA-12CLIA2021-01-13
00817405021222UScreen®USSCup-10MMO300USSCup-10MMO3002021-01-13
10817405021304iScreen™IS1 MET-DX2 IS1 MET-DX2 2020-08-21
10817405021311iScreen™IS12-DX2 IS12-DX2 2020-08-21
10817405021328iScreen™IS12BUP-DX2 IS12BUP-DX2 2020-08-21
10817405021373UScreen®USSCupA-11CLIALCUSSCupA-11CLIALC2021-05-25
00817405022229iScreen™ABTDUAW110704DABTDUAW110704D2022-06-16
00817405023240iScreen™ABTDUAW112701AABTDUAW112701A2022-11-09
00817405023257iScreen™ABTDUAW16701AABTDUAW16701A2022-11-09
00817405023264iScreen™ABTDUAW17701AABTDUAW17701A2022-11-09
00817405023271iScreen™ABTDUAW110701AABTDUAW110701A2022-11-09
00817405023288iScreen™ABTDUAW110702BABTDUAW110702B2022-11-09
00817405023295iScreen™ABTDUAW15701AABTDUAW15701A2022-11-09
00817405023301iScreen™ABTDUAW113701AABTDUAW113701A2023-02-10
00817405023318iScreen™ABTDOAW14701AABTDOAW14701A2022-11-09
00817405023325iScreen™ABTDUAW17702BABTDUAW17702B2022-11-09
00817405023332iScreen™ABTDOAW17701AABTDOAW17701A2022-11-09
00817405023349iScreen™ABTDUAW110703CABTDUAW110703C2022-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414595849TD TRICYC ANTIDEPRESSANT ASSAY, TCASiemens Healthcare Diagnostics Inc.LFH2018-12-01
00868348000256Status Toxi CupLifesign L.L.C.LFH2017-05-17
10868348000253Status Toxi CupLifesign L.L.C.LFH2017-05-17
00816565020960Fastect II Drug Screen Dipstick TestAMEDITECH INC.LFH2017-03-31
00748349000311QuikScreenSYNTRON BIORESEARCH, INC.LFH2017-02-27
00748349000274QuikScreenSYNTRON BIORESEARCH, INC.LFH2017-02-24
00748349000243QuikScreenSYNTRON BIORESEARCH, INC.LFH2016-12-13
00748349000199QuikScreen SYNTRON BIORESEARCH, INC.LFH2016-11-04
20748349000193QuikScreen SYNTRON BIORESEARCH, INC.LFH2016-11-04
00748349000175QuikScreen Multi 12 Drug Cup TestSYNTRON BIORESEARCH, INC.LFH2016-10-21
20748349000179QuikScreen Multi 12 Drug Cup TestSYNTRON BIORESEARCH, INC.LFH2016-10-21
00748349000106QuikScreen Multi 11 Drug Cup TestSYNTRON BIORESEARCH, INC.LFH2016-10-04
00748349000113QuikScreenSYNTRON BIORESEARCH, INC.LFH2016-10-04
20748349000117QuikScreenSYNTRON BIORESEARCH, INC.LFH2016-10-04
10864040000331QTEST 11 (25 pack)MEDIMPEX UNITED, INCLFH2016-09-30
10864040000348QTEST 12 (25 Pack)MEDIMPEX UNITED, INCLFH2016-09-30
00863480002106LifeSign QuikScreen 11Lifesign L.L.C.LFH2016-09-24
00863480002113Status Toxi Cup 13+4Lifesign L.L.C.LFH2016-09-24
00842768001277Syva® RapidTest d.a.u.® TCASiemens Healthcare Diagnostics Inc.LFH2016-09-24
20863480002117Status Toxi Cup 13+4Lifesign L.L.C.LFH2016-09-24
00630414551036ADVIA® Chemistry TCASiemens Healthcare Diagnostics Inc.LFH2016-09-24
10763924086532ACCUTEST - 5 Drug Test Cup *CLIA-Waived*JANT PHARMACAL CORPORATIONLFH2016-09-23
10763924087539ACCUTEST - 6 Drug CupJANT PHARMACAL CORPORATIONLFH2016-09-23
10763924811530ACCUTEST Drug Test Cup 11-Panel CLIA-WaivedJANT PHARMACAL CORPORATIONLFH2016-09-23
10763924822536ACCUTEST Drug Test Cup 12-Panel CLIA-WaivedJANT PHARMACAL CORPORATIONLFH2016-09-23
10763924823533ACCUTEST Drug Test Cup 13-Panel CLIA-WaivedJANT PHARMACAL CORPORATIONLFH2016-09-23
00817405020010Alere iCup Dx 14Instant Technologies, Inc.LFH2016-09-19
00817405020027Alere iCup Dx 14Instant Technologies, Inc.LFH2016-09-19
00817405020171Alere iScreen DxInstant Technologies, Inc.LFH2016-09-19
00884883001183DRI Tricyclics Serum Tox AssayMicrogenics CorporationLFH2016-09-12